Apixaban in Subjects With Peritoneal Dialysis

NCT04006093 | Completed Phase 1

• 1 other identifier: 19-060
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the pharmacokinetics of a single oral dose of apixaban (5mg) in participants with dialysis peritoneal versus participants with normal renal function.

Conditions

Chronic Renal Insufficiency; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (2)

• Apixaban area Under the curve

  Measurement of apixaban plasma concentrations at different times.

  Day 3

• Apixaban maximum plasma concentration

  Measurement of apixaban plasma concentrations at different times.

  Day 3

Secondary Outcomes (5)

• anti-Xa activity

  Hour 0, Hour 3, Hour 9 and Hour 72

• TP activity

  Hour 0, Hour 3, Hour 9 and Hour 72

• TCA activity

  Hour 0, Hour 3, Hour 9 and Hour 72

• Apixaban urinary elimination

  Day 3

• Apixaban maximum peritoneal concentration

  day 3

Study Arms (2)

Participants in peritoneal dialysis

EXPERIMENTAL

apixaban single dose 5mg in participants in peritoneal dialysis

Drug: Apixaban single dose 5mg

Participants with normal renal function

EXPERIMENTAL

apixaban single dose 5mg in participants with normal renal function

Drug: Apixaban single dose 5mg

Interventions

Apixaban single dose 5mg DRUG

Apixaban oral single dose 5mg

Participants in peritoneal dialysis; Participants with normal renal function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with 21\<BMI\<40
• French participant
• Participant able to consent
• Participant with social insurance
• Participant on peritoneal dialysis for at least 3 months with end-stage renal disease treated

You may not qualify if:

• Participant with hypersensibility reactions to apixaban
• Participant with a history of major bleeding
• Participant already on anticoagulant
• Participant on non-stearoid anti-inflammatory at anti-inflammatory dosage \> 300 mg
• Participant on potent inhibitors of CYP 3A4 and P-gp
• Participant on inducers of CYP3A4 and P-sp
• Participant with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
• Participant receiving or having received antibiotic treatment within 14 days prior to study
• Pregnant or lactating women
• Participant with known hypersensitivity reactions to icodextrin
• Participant not supporting an intraperitoneal volume of 2 liters (only participant with peritoneal dialysis)
• Participant with "Normal renal function" with glomerular filtration rate \< 90 ml/min

Sponsors & Collaborators

• University Hospital, Caen: lead
• University Hospital, Rouen: collaborator

Study Sites (1)

CHU Caen

Caen, 14000, France

Location

Related Publications (1)

• Peyro-Saint-Paul L, Bechade C, Cesbron A, Debruyne D, Brionne M, Brucato S, Hanoy M, Dumont A, Briant AR, Parienti JJ, Lobbedez T, Ficheux M. Effect of peritoneal dialysis in end-stage renal disease on apixaban pharmacokinetics. Nephrol Dial Transplant. 2023 Jul 31;38(8):1918-1920. doi: 10.1093/ndt/gfad087. No abstract available.

  PMID: 37169987 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

apixaban

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of participants will receive one single-dose of 5 mg of apixaban: the first group of participants with a normal renal function, the second group contains participants with end-stage renal disease treated with peritoneal dialysis.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: July 2, 2019
• Study Start: December 8, 2019
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: March 27, 2026

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

FR (1)